SAN FRANCISCO, CA—Patients from the advanced cirrhosis cohort of the Phase 3 ALLY-1 study had high rates of sustained virologic response (SVR12) when treated with daclatasvir/sofosbuvir/ribavirin, as well as improved clinical and biochemical indicators of liver disease, investigators reported at The Liver Meeting® 2015.

In “multiple high-need patient populations with chronic HCV infection,” the “pangenotypic combination of daclatasvir and sofosbuvir, with or without ribavirin, has achieved SVR12 rates of 82% to 98%,” Robert J. Fontana, MD, University of Michigan Medical Center, Ann Arbor, MI, noted.

For example, in the open-label ALLY-1 study, “daclatasvir + sofosbuvir + ribavirin achieved SVR12 in 83% of patients with advanced cirrhosis and in 94% of those with post-liver transplant recurrence.”

In this analysis, he and his colleagues evaluated changes over time in liver disease parameters among patients from the advanced cirrhosis cohort of ALLY-1. The trial enrolled treatment-naive or treatment-experienced adults who had HCV infection of any genotype (GT).

Those in the advanced cirrhosis cohort (n=60) received 12 weeks of treatment with daclatasvir 60mg plus sofosbuvir 400mg once daily and ribavirin. Initially, sofosbuvir was administered at 600mg/day; however, the dose was adjusted for hemoglobin and creatinine clearance. The primary endpoint was HCV RNA <LLOQ (25 IU/mL) at post-treatment Week 12 in patients with GT1 infection.

A total of 60% of patients were treatment-experienced and 6 patients had hepatocellular carcinoma (HCC). Genotypes were as follows: GT1a, 57%; GT1b, 18%; GT2, 8%; GT3, 10%; and GT4, 7%. At baseline, Child-Pugh classifications were A, 20%; B, 53%; and C, 27%. MELD scores ranged from 8 to 27.

The primary endpoint, SVR12, was achieved by 11 patients (92%) with Child-Pugh A, 30 (94%) with B, and 9 (56%) with C. Four patients, all of whom had HCC, underwent transplantation during treatment and were excluded from analysis.

In addition, in 30 of 45 patients who achieved SVR12, MELD scores improved or remained stable. This was also observed in 6 (100%) patients with Child-Pugh C disease and 6 (60%) of those who did not attain SVR12.